Daiichi Sankyo gets EU OK for Lixiana anticoagulant

Daiichi Sankyo's Lixiana has become the fourth novel oral anticoagulant (NOAC) to be granted approval in the EU.

The European Commission has given the green light for Lixiana (edoxaban) to be used to prevent stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors, such as congestive heart failure or hypertension, and also to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE).

The once-daily Factor Xa-inhibitor - also sold as Savaysa in some markets - has already been approved in the US, Japan and Switzerland.

It is competing in the NOAC category against two other drugs in that class - Pfizer's Eliquis (apixaban) and Bayer/Johnson & Johnson's Xarelto (rivaroxaban) - as well as Boehringer Ingelheim's thrombin inhibitor Pradaxa (dabigatran).

All the NOACs are seeing their use increase as they replace older anticoagulants such as warfarin, thanks to data showing they are less prone to cause bleeding side effects as well as less burdensome administration and monitoring requirements.

"AF-related stroke as well as DVT and PE create a significant societal and economic health burden," said Jan van Ruymbeke, the head of Daiichi Sankyo Europe.

"Once-daily Lixiana offers the unique combination of an easy-to-use oral anticoagulant with proven efficacy across a broad range of patients and a better bleeding profile compared to well-managed warfarin," he added.

Pradaxa and Eliquis are given twice-daily, while Xarelto is administered once-daily, and the latter drug is currently leading the NOAC category with Pfizer and Boehringer's drugs in second and third places, respectively.

Daiichi Sankyo hopes that Lixiana's profile will help it put in a good showing in the market, although it has a lot of ground to catch up considering Xarelto chalked up sales of $3.7bn last year.

In contrast, sales of Lixiana reached 3.6bn Yen ($29m) in fiscal 2014 and according to the company's own forecasts will reach around 5bn Yen this year.

The product also hit a snag in the US earlier this year when the FDA approved it with a boxed warning saying it is less effective in patients with whose creatinine clearance - a measure of renal function - was above a threshold level (95mL/min).

These patients have a greater risk of stroke compared with similar patients treated with warfarin, according to the FDA.

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